Psychotherapy Feasibility Pilot of the Carolina Recovery From Depression Protocol

NCT06590038 | Completed

• 1 other identifier: 23-1988
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn whether an single session intervention can reduce psychological impairment in adult individuals with moderate depression. The main questions it aims to answer are: Is this evidence-based intervention acceptable to study participants? Is this evidence-based intervention feasible to implement in a single session? Is there evidence that the evidence-based intervention reduces psychological impairment in adults with moderate to severe depression? Participants will complete:

• an in-depth diagnostic screening interview prior to enrollment
• a set of mental health questionnaires at baseline and two weeks post-intervention
• a 3-hour, evidence-based, single session psychotherapeutic intervention with a trained clinician

Conditions

Depression, Unipolar

Keywords

Depression; Major Depressive Disorder; Psychotherapy; Single Session Intervention

Outcome Measures

Primary Outcomes (1)

• CARED Treatment Experience Survey

  A brief survey which probes the qualitative experience of participants during the intervention (i.e., tolerability, their level of engagement, satisfaction with treatment). Participants respond to eight items, rated on a 4-point Likert scale (1 - Not at all to 4 - Completely) to indicate their level of agreement with each item. Higher scores on the measure indicate greater tolerability, satisfaction, and endorsement of treatment. Total possible scores range from 8 to 32.

  Immediately post-intervention (same day)

Secondary Outcomes (14)

• Change from baseline on Behavioral Activation Scale at two weeks post-intervention

  Baseline and Two Weeks post-intervention

• Change in baseline Repetitive Thinking Questionnaire - 10 item form to two weeks post-intervention

  Baseline and Two weeks post-intervention

• Change from baseline on Snaith-Hamilton Pleasure Scale at two weeks post-intervention

  Baseline and Two weeks post-intervention

• Change from baseline on Behavioral Inhibition and Behavioral Activation Scale - Inhibition Subscale at two weeks post-intervention

  Baseline and Two weeks post-intervention

• Change from baseline on Behavioral Inhibition and Behavioral Activation Scale - Activation Drive Subscale at two weeks post-intervention

  Baseline and Two weeks post-intervention

Study Arms (1)

Psychotherapy Arm

EXPERIMENTAL

Behavioral: Single Session Psychotherapy Intervention

Interventions

Single Session Psychotherapy Intervention BEHAVIORAL

This is a single session intervention which incorporates elements from second- and third wave psychotherapies (Acceptance and Commitment Therapy and Behavioral Activation), as well as basic psychoeducation. Session will take approximately three hours in total, with the option for breaks between blocks of session.

Psychotherapy Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of 18 years or older
• Able to provide informed consent
• Willing to comply with all study procedures and be available for the duration of the study
• Speak and understand English
• Diagnostic and Statistical Manual (DSM)-5 diagnosis of major depressive disorder (MDD) as confirmed by semi-structured clinical assessment
• Meet a cutoff of at least a moderate depression score on the Beck Depression Inventory (BDI-II) (≥ 20)

You may not qualify if:

• Participants must not have current active suicide intent as determined by the Columbia Suicide Severity Rating Scale (C-SSRS)
• Participants must not meet criteria for current severe substance use disorder, anorexia nervosa, or active psychosis as assessed by psychodiagnostic assessment
• Any participants taking psychotropic medication must be on a stable dose for at least 4 weeks with no planned dose changes within the next 4 weeks.
• Participants able to birth must not be pregnant or breastfeeding.
• Participants may not have any medical or neurological illness for which symptom presentation or treatment could interfere with study participation
• Participants may not have undergone prior brain surgery
• Participants may not have any brain devices/implants, including cochlear implants and aneurysm clips
• Participants may not have had brain injury or concussion within the last three months
• Participants may not have a history of brain injury requiring current treatment

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• The Foundation of Hope for Research and Treatment of Mental Illness: collaborator

Study Sites (1)

Carolina Center for Neurostimulation

Chapel Hill, North Carolina, 27516, United States

Location

MeSH Terms

Conditions

Depressive Disorder; Depression; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Flavio Frohlich, Ph.D.

  Univeristy of North Carolina Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2024
• First Posted: September 19, 2024
• Study Start: March 3, 2025
• Primary Completion: April 24, 2025
• Study Completion: April 24, 2025
• Last Updated: June 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Individual participant data (IPD) and supporting information will be available nine to thirty-six months following publication.
• Access Criteria: Individual researchers and research groups will be able to request access to deidentified IPD and supporting information with approved IRB, IEC, or REB and an executed Data Use Agreement (DUA) with University of North Carolina (UNC) Chapel Hill.

Locations

US (1)